Based on the evidence demonstrating that Synthetic Nicotine products are generally intended to address disease or affect the structure or function of the body, there is a strong case that the FDA has the legal authority to regulate Synthetic Nicotine products as drugs. That FDA can regulate a particular product, however, does not mean that it will or that it should. Indeed, the FDA often exercises its discretion not to enforce requirements for a variety of reasons, and this may be particularly common for innovative products.166

In this section, therefore, we explore the question of whether FDA should regulate Synthetic Nicotine products as drugs. We identify several reasons why regulating Synthetic Nicotine products as drugs would be beneficial and not unreasonably burdensome on industry. We conclude that, not only does FDA have the authority to regulate these products as drugs, it would serve FDA’s public health mission—and the public—for it to do so, even when Synthetic Nicotine products are marketed without explicit smoking cessation claims.

Treating Like Products Similarly

It is a maxim in administrative law and theory that “like cases should be treated alike.” Such consistency is viewed as fair, and indicative of an impartial, rational decision-making process that provides predictability for regulated entities.168 This notion of consistency is codified in the Administrative Procedure Act, which permits courts to set aside “arbitrary and capricious” agency decisions169—the paradigmatic example of which is a decision that treats like cases differently.

Allowing the subset of synthetically-derived e-liquids to evade regulation, while regulating tobacco-derived e-liquids, may unfairly give Synthetic Nicotine products an advantage in the marketplace. Regulating Synthetic Nicotine as a drug would allow the FDA to achieve the policy goal of treating all nicotine-containing e-cigarettes and e-liquids—regardless of whether they are tobacco-derived or not—more similarly than it otherwise could. The FDA is not likely to judged “arbitrary and capricious” by a court for excluding Synthetic Nicotine products from its scheme for tobacco regulation, because the way the statute and the courts have defined tobacco products gives the FDA a legitimate reason for doing so. The FDA generally does not have the authority to regulate Synthetic Nicotine as a tobacco product, under the TCA, because the nicotine is not derived from tobacco, and the FDA does not have the authority to regulate tobacco-derived e-liquids (as “customarily marketed”) as drugs under Sottera. Nevertheless, because there is no evidence that Synthetic Nicotine differs from tobacco-derived nicotine in its biological impacts on users, there is no scientific or public health rationale for treating the two categories of products differently.

The FDA’s schemes for regulating tobacco and drugs are distinct, but they parallel each other in important ways. As is true for drugs, tobacco products might be deemed misbranded if their labeling is false or misleading or fails to comply with FDA requirements, such as failing to disclose the seller or product ingredients, or failing to include relevant warnings. Similarly, both drugs and tobacco products might be deemed adulterated if they are contaminated, manufactured in insanitary conditions, or manufactured through methods that do not comply with good manufacturing practices. In short, both regulatory schemes are designed to ensure transparency, honesty, and safety.

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Synthetic NicotineSynthetic Nicotine is used for E-Cigarettes
Based on the evidence demonstrating that Synthetic Nicotine products are generally intended to address disease or affect the structure or function of the body, there is a strong case that the FDA has the legal authority to regulate Synthetic Nicotine products as drugs. That FDA can regulate a particular product, however,...